Efficacy of Alendronate Versus Placebo in the Treatment of HIV-associated Osteoporosis (ANRS120)

This study has been completed.

Sponsor:

French National Agency for Research on AIDS and Viral Hepatitis

ClinicalTrials.gov Identifier:

NCT00120757

First Posted: July 19, 2005

Last Update Posted: December 22, 2011

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
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Osteopenia and osteoporosis are being described more frequently in people with HIV infection. This study will test the efficacy of alendronate in comparison with a placebo after 2 years, in people with primary osteoporosis. People will receive the recommended adequate intake of calcium and vitamin D.

To measure the prevalence of osteoporosis in HIV patients and to detect risk factors in a large cohort of HIV patients from the screening phase

Eligibility

Information from the National Library of Medicine

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Osteoporosis resulting from a cause other than HIV: vitamin D deficiency (in that case, after receiving high-dose calcium and vitamin D for 1 month, patients will be randomized without a new screening), renal failure, heart failure (NHYA class III or IV), treatment with glucocorticoid at a dose over or equal to 0.5mg/kg/d for 15 days or more at time of inclusion or during the previous 6 months; thyroid or other endocrine disease if untreated for more than 6 months; hypercalciuria

Testosterone below normal if treatment is hormonal

BMI below or equal to 18

Severe lung failure

Chronic alcohol intoxication

Ongoing opportunistic infection

Gastric ulcer of disease interfering with oesophageal motility in the previous 3 months

History of treatment for osteoporosis

History of malignancy in the previous 5 years (except skin cancer and Kaposi)

Cytotoxic chemotherapy or cytokine therapy

Liver cirrhosis

Breast feeding

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00120757